Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06516510 | RECRUITING | Metastatic Prostate Cancer

A Dosimetry Study of Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®) in Patients With Non-curative Metastatic Prostate Cancer
Sponsor:

Blue Earth Therapeutics Ltd

Brief Summary:

A randomised, multi-centre, intra-patient imaging and dosimetry crossover study of lutetium (177Lu) rhPSMA 10.1 and lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) in patients with non-curative metastatic prostate cancer

Condition or disease

Metastatic Prostate Cancer

Intervention/treatment

lutetium (177Lu) rhPSMA 10.1 and Pluvicto®

Phase

EARLY_PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 24 participants
Masking : SINGLE
Primary Purpose : OTHER
Official Title : A Randomised, Multi-centre, Intra-patient Imaging and Dosimetry Crossover Study of Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®) in Patients With Non-curative Metastatic Prostate Cancer
Actual Study Start Date : 2024-10-31
Estimated Primary Completion Date : 2025-10
Estimated Study Completion Date : 2026-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 60 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Male patient aged ≥60 years old at Visit 1 (Screening).
  • * Patient has non-curative PSMA-positive prostate cancer that has spread outside of the prostate gland and is undergoing or being planned for radioligand therapy.
  • * At least 1 PSMA-positive lesion that can be outlined on PET or CT and ≥1 cm in the short axis measured on either modality, for the purpose of dosimetry.
  • * Adequate normal organ function as demonstrated by
    • * Absolute neutrophil count ≥1.5 × 109/L
    • * Platelets ≥100 × 109/L
    • * Haemoglobin ≥9 g/dL
    • * Total bilirubin \<2 × the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome, ≤3 × ULN is permitted.
    • * Alanine aminotransferase (ALT) or aspartate transaminase (AST) ≤3.0 × ULN or ≤5.0 × ULN for patients with liver metastases.
    • * Estimated glomerular filtration rate (using Chronic Kidney Disease Epidemiology Collaboration Creatinine Equation \[2009\]) \>50 mL/min.
    • * Willing to provide signed and dated written informed consent form (ICF) prior to any study specific procedures
    • * Male patients must agree not to father children or donate sperm during the study and for at least 14 weeks after the last study treatment.
    Exclusion Criteria
    • * Known hypersensitivity to lutetium (177Lu) rhPSMA 10.1 or lutetium (177Lu) vipivotide tetraxetan, or any of the constituents.
    • * Previous treatment with any radiopharmaceutical therapy in the 42 days or 5 half-lives prior to Visit 1 (Screening).
    • * Any significant metallic implants or objects, which may in the opinion of the investigator, affect image quality and/or dosimetry calculations.
    • * Severe claustrophobia, inability to lie flat or fit into the scanner, or any other inability to tolerate the SPECT/CT scan protocol
    • * Any change to prostate cancer medication or new prostate cancer therapy, prostate cancer surgical procedure within 42 days prior to screening or during the study.
    • * Any medical or psychiatric condition, including rapidly progressive prostate cancer, that in the investigator's judgment, makes the patient unsuitable for the study
    • * Participation in other studies involving other IMPs within 42 days or 5 half lives (whichever is longer) prior to Visit 1 (Screening) and/or during study participation
A Dosimetry Study of Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®) in Patients With Non-curative Metastatic Prostate Cancer

Location Details

NCT06516510

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

Biogenix Molecular

Miami, Florida, United States, 33165

RECRUITING

United States, Georgia

Emory University Hospital

Atlanta, Georgia, United States, 30322

RECRUITING

Netherlands, Gelderland

Radboud UMC

Nijmegen, Gelderland, Netherlands, 6525GA

RECRUITING

Spain, Navarra

Clinic University of Navarra - Pamplona

Pamplona, Navarra, Spain, 31008

RECRUITING

Spain,

Clinic University of Navarra

Madrid, Spain, 28027

RECRUITING

Spain,

Clara Campal Oncological Center

Madrid, Spain, 28050